‘Explosive growth’ of biomarker discovery and development fuels demand for biospecimens, thus creating a new revenue source for clinical laboratories and pathology groups

Are health information networks alive and well in the United States? This sector of healthcare has been quiet in recent years. However, there is one statewide health information exchange (HIE) that is doing innovative things with clinical laboratory specimens.

The Delaware Health Information Network (DHIN) has entered into a novel collaboration that may help address the medical research community’s growing need for clinical specimens. At the same time, this agreement will also provide a much-needed new revenue stream for participating medical laboratories and hospitals.

With Medicare and health insurers reducing reimbursements for laboratory tests, medical laboratories and pathology groups are facing uncertain financial times. However, DHIN’s new partnership with iSpecimen of Massachusetts highlights the potential value of remnant clinical specimens—samples that otherwise would be discarded once patient testing is complete.

“The value of digitizing medical data extends beyond the obvious value of supporting direct patient care,” DHIN Chief Executive Officer Jan Lee, MD, said in a news release. “With informed patient consent, digital data can also help match clinical specimens with very specific research criteria. DHIN is proud to play a role in supporting such efforts to find new breakthrough treatments and cures.”

Funneling Pathology Data Value Back into Care

DHIN serves all of Delaware’s acute care hospitals, major laboratories, radiology facilities, and skilled nursing facilities, as well as three Maryland hospitals. DHIN is the first data aggregator in the iSpecimen network, which today includes more than 50 hospitals and commercial lab, 400 clinics and practice groups, 10 biorepositories, and a large blood center.

Delaware Health Information Network CEO Jan Lee, MD, believes her organization’s collaboration with iSpecimen not only will benefit the medical research community but also will reduce the fees paid to DHIN by member hospitals and medical laboratories that take part in the initiative. (Photo copyright: Delaware Health Information Network.)

“They realized we have data that goes beyond any one hospital,” Lee told Healthcare Informatics. “And you need the data to identify the specimens that you are interested in out of the state HIE. We have data from every hospital and every commercial lab in Delaware. If they used our data source to identify the specimens of interest, they will get a higher hit rate.”

Union Hospital in Elkton, Md., is the first DHIN member to commit to the partnership.

“Union Hospital is thrilled to kick off this initiative and begin to reap value that can be put back into care,” Union Hospital Chief Information Officer Anne Lara, EdD, RN, CNE, CPHIMS, stated in the DHIN news release. “As a small community hospital, it’s great to know that we can make a significant impact in this way by helping researchers accelerate medical discoveries to help patients now and in the future.”

Participating Hospitals Pay Reduced Fees to DHIN

In addition to making a contribution to medical research, DHIN hospitals and laboratories that join the iSpecimen partnership will benefit from reduced DHIN fees. According to Health Data Management, DHIN will credit 75% of the transaction fees it receives from iSpecimen back to the hospital or laboratory that donated the clinical specimen. iSpecimen generates its revenue by charging participating researchers for the matching service.

“The specimens and data going through your clinical laboratory are assets in a way you may not recognize,” stated iSpecimen founder and Chief Executive Officer Christopher Ianelli, MD, PhD, at the 2016 Executive War College on Laboratory and Pathology Management in New Orleans. “They are assets that have value, around which you can create another business line that is meaningful and will help not only your top line and your bottom line, but also the research community at large.”

Value of Clinical Laboratory Specimen Data

Founded in 2009, iSpecimen has its origins at Brigham and Women’s Hospital in Boston, which started using information in its own hospital electronic health record (EHR) system to identify specimens of interest to their researchers rather than pay a specimen bank to order specimens that fit specific conditions.

iSpecimen founder and Chief Executive Officer Christopher Ianelli, MD, PhD, told pathologists attending the 2016 Executive War College on Laboratory and Pathology Management in New Orleans that the specimens and data going through their laboratories “are assets that have value, around which you can create another business line that is meaningful and will help not only your top line and your bottom line, but also the research community at large.” (Photo copyright: The Dark Report.)

iSpecimen uses proprietary technology to watch the flow of patients and soon-to-be-discarded clinical samples at its network of hospitals, medical labs, and blood centers. Clinical data associated with remnant specimens is de-identified and matched to research studies across academia and industry. When matches are made, iSpecimen instructs laboratory personnel to ship the specimens to its research customers.

Patients must provide informed consent to have their specimens used in an active research project, a requirement that has muted enthusiasm for the joint venture among some DHIN members.

“We have approached the other hospitals in our network, and the response has been tepid in some cases and actively opposed in other cases,” Lee stated in the Healthcare Informatics article. “One lab said they think it will be a burden to collect the upfront consent and hold the specimens … everyone has so much on their plate. This industry is in such a state of volatility, so something that is extra and isn’t necessary is tough to ask of people.”

However, in an exclusive interview with Dark Daily, DHIN Chief Operating Officer Randall Farmer stated that two medical laboratories are in the process of finalizing agreements to join the program and other DHIN organizations are in the midst of “active discussions.”

And, in his remarks at the Executive War College, Ianelli described the demand for biospecimens as “booming” due to the “explosive growth” of biomarker discovery and development in a new era of precision medicine. He said the global research biospecimen market for blood and biofluids and solid tissue is growing 15% to 20% per year, creating a “multiple billion dollar industry,” according to Visiongain’s 2014 Industry Report.

Ianelli says biotechnology, pharmaceutical, and diagnostic companies have a “growing hunger and demand for specimens [and their associated data sets] to drive all of their research to help them identify the next round of biomarkers that are going to become the next round of analytes for diagnostics.”